Gambro Phoenix Hemodialysis Machine, Model numbers: 6022933700, 6023006700, 6022966700, Gambro Dasco S.p.A., Italy.
FDA Recall Z-0200-2007 · Posted 2006-11-21
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Recalling FirmGambro Renal Products, Inc.
Recall StatusTerminated
Product CodeKDI
Date Initiated2006-05-12
Date Terminated2012-01-03
Product Quantity613 machines (US), 170 machines (foreign)
Reason for Recall
Defective Heat Exchanger/membrane; this may result in perforation of the membrane thus allowing the presence of infectious organisms and/or pathogens to pass from patient to patient.
Firm Action
Consignees were notified by fax on 05/12/2006 and by letter on 05/16/2006. Until it was determined that their Phoenix system did not have an affected heat exchanger, users were instructed to disinfect the hydraulics flow path after each patient treatment. Gambro personnel will inspect each system and replace any affected heat exchangers.
Root Cause
Nonconforming Material/Component
Distribution Pattern
Worldwide Distribution, USA, including VA facilities in GA and NC. Foreign distribution to Canada, Korea and Mexico.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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